NOTICE: Applications submitted in response to this Funding Opportunity
Announcement (FOA) for Federal assistance must be submitted electronically
through Grants.gov (http://www.grants.gov) using the SF424
Research and Related (R&R) forms and SF424 (R&R) Application Guide. APPLICATIONS
MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA
must be read in conjunction with the application guidelines
provided with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A
registration process is necessary before submission and applicants are highly
encouraged to start the process at least four weeks prior to the grant
submission date. See Section
IV.

Two steps are required for on time submission:

1)
The application must be submitted to Grants.gov by 5:00 p.m. local time (of the applicant institution/organization) on the submission date (see “Key Dates”
below).

2)
Applicants must complete a verification step in the eRA Commons within two business
days of notification from NIH. Note: Since email can be unreliable, it is the
responsibility of the applicant to periodically check on their application
status in the Commons.

The National Institute of Neurological Disorders
and Stroke (NINDS) encourages submission of investigator-initiated research
grant applications to study mechanisms of transmission and dissemination of
Transmissible Spongiform Encephalopathies (TSEs).

This funding
opportunity announcement (FOA) will use the NIH Exploratory/Developmental Grant
(R21) award mechanism but runs in parallel with two program announcements of
identical scientific scope that utilizes the traditional research project grant
(R01) [PA-05-096] and small
research grant (R03) mechanisms [PA-06-192],
respectively.

Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. The total amount awarded and the number of awards will depend upon
the mechanism numbers, quality, duration, and costs of the applications received.

Eligible
organizations include: For-profit organizations; Non-profit organizations; Public or
private institutions, such as universities, colleges, hospitals, and
laboratories; Eligible agencies of the Federal government; Units of State
government; Units of local government ; Foreign Institutions; Domestic
Institutions; Faith-based or community-based organizations; and units of state
or local tribal governments.

Eligible Project Directors/Principal Investigators (PD/PIs): Any individual with the skills, knowledge and resources necessary to carry out the proposed research, is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

An R21 is not
renewable.

Applicants
may submit more than one application, provided they are scientifically
distinct.

See Section IV.1 for application materials. The SF424 (R&R)
Application Guide for this FOA is located at these Web sites:

The
National Institute of Neurological Disorders and Stroke (NINDS) encourages
investigator-initiated research grant applications to study the mechanisms of
transmission and dissemination of transmissible spongiform encephalopathies
(TSEs). TSEs or “prion diseases” are neurodegenerative disorders that can lead
to dementia, motor dysfunction and eventually death. Iatrogenic transmission of
prion disease has been reported (transplantation of cadaveric cornea or dura
mater, or injection of cadaveric human growth hormone); however the best known
mechanism of natural transmission of TSEs is via the gastrointestinal tract
through ingestion of contaminated food. Once in the digestive tract, prions are
able to disseminate to the peripheral lymph organs and the Central Nervous
System (CNS). This PA is intended to expand research on how these diseases can
spread within an affected population and how infectious prions are then
distributed through the body and ultimately to the CNS.

Background

Prions
are infectious proteins, responsible for different neurodegenerative diseases,
which involve modification of the normal cellular prion protein PrP c to the
mutated form PrP Sc . Prion diseases may be manifest as infectious, genetic and
sporadic disorders, all resulting from the accumulation of PrP Sc in the brain
and in lymphoid tissue of TSEs patients with clinical manifestations often in
older individuals. Prion diseases include bovine spongiform encephalopathy
(BSE) in cattle, scrapie of sheep, Chronic Wasting Disease (CWD) in mule deer
and elk, and Kuru and Creutzfeldt-Jakob Disease (CJD) in human. TSEs can be
spread through the consumption of infected tissue derived from contaminated
sources. In humans, the consumption of contaminated beef has been linked to an
outbreak of variant Creutzfeldt-Jakob Disease (vCJD). Little is known about the
natural spread of TSEs within affected populations. The epidemiology of disease
transmission among herbivores suggests that a vector (s) and/or reservoir(s)
may be involved in the spread of these diseases. Understanding the natural
pathways by which TSEs arise and are transmitted may be critical for protecting
populations at risk from acquiring these diseases. In addition, very little is
known regarding the dissemination of the pathogen from the point of entry.
Recent evidence suggests that ingested prions may spread through the lymphatic
system to the spleen where the agent may enter the autonomic nervous system.
Other evidence suggests that a PrP Sc -ferritin complex and ferritin receptors
may play a role in transporting these agents across the intestinal epithelial
barrier and into the nervous system. Additional research on these and other
mechanisms of transmission of TSE diseases among species and their
dissemination to the CNS is needed.

Scope
and Objective

The
objective of this announcement is to encourage investigator-initiated research
grant applications to study the mechanisms of transmission and dissemination of
transmissible spongiform encephalopathies (TSEs). The following topics are
included as suggestions and examples of potential research areas relevant to
this announcement:

Studies
of the natural spread of TSEs within species.

Studies
of the spread of TSEs across species barriers.

Studies
addressing the mechanisms involved in the transport of prions from the
gastrointestinal tract or other mode of entry to the CNS. Examples could
include studies of prion transmission across the blood brain barrier (BBB) or
by the intranasal route.

Studies
elucidating the roles of age-related factors in the transport and entry into
the CNS and the consequent pathological manifestations.

Studies
addressing the possible involvement of inflammatory or other cofactors in the
dissemination of TSEs agents.

Studies in
animal models aimed to understand the mechanisms of transmission and
dissemination of TSEs.

This funding opportunity will
use the National
Institutes of Health (NIH) Exploratory/Developmental Research Grant (R21). As
an applicant, you will be solely responsible for planning, directing, and
executing the proposed project.

As an
Exploratory/Developmental mechanism, the R21 Grant is intended to support
projects that: 1) assess the feasibility of a novel avenue of investigation 2)
involve high risk experiments that could lead to a breakthrough in a particular
field or 3) demonstrate the feasibility of new technologies that could have
major impact in a specific area. To be eligible for consideration, proposals
must be distinct from those traditionally submitted through the R01 mechanism.
For example, projects designed to produce incremental advances in knowledge in
a well-established area will not be considered. Proposals submitted under this
mechanism should be limited to those with the potential for truly
ground-breaking impact.

This funding opportunity uses just-in-time concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

Exploratory/developmental
grant support is for new projects only; competing renewal (formerly “competing
continuation”) applications will not be accepted. Up to two resubmissions
(formerly “revisions/amendments") of a previously reviewed
exploratory/developmental grant application may be submitted. See NOT-OD-03-041,
May 7, 2003.

2. Funds Available

The total amount awarded and
the number of awards will depend upon the mechanism, duration, and costs of the
applications received, and are contingent upon the availability of funds.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Direct costs are limited to $275,000 over the two years of the R21 award, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NOT-OD-05-004.

Section
III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an)
application(s) if your organization has any of the following characteristics:

For-profit organizations

Non-profit organizations

Public or private institutions,
such as universities, colleges, hospitals, and laboratories

Units of State government

Units of local government

Eligible agencies of the Federal
government

Foreign Institutions

Domestic Institutions

Faith-based or community-based
organizations

Units of State Tribal government

Units of Local Tribal government

1.B.
Eligible Individuals Any individual with the
skills, knowledge, and resources necessary to carry out the proposed research
is invited to work with their institution to develop an application for
support. Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for NIH programs.

To download a SF424 (R&R) Application Package and
SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for
this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

The individual designated as the
PD/PI on the application must also be registered in the NIH eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.

The PD/PI must hold a PD/PI
account in the Commons and must be affiliated with the applicant
organization. This account cannot have any other role attached to it other
than the PD/PI.

This registration/affiliation
must be done by the Signing Official (SO) or their designee who is already
registered in the Commons.

Both the PD/PI and SO need
separate accounts in the NIH eRA Commons since both are required to verify
the application.

Note that if a PD/PI is also an NIH peer-reviewer with an
Individual DUNS and CCR registration, that particular DUNS number and CCR
registration are for the individual reviewer only. These are different than any
DUNS number and CCR registration used by an applicant organization. Individual
DUNS and CCR registration should be used only for the purposes of personal
reimbursement and should not be used on any grant applications submitted to the
Federal Government.

Several of the steps of the registration process could
take four weeks or more. Therefore, applicants should immediately check with
their business official to determine whether their institution is already
registered in both Grants.gov and the Commons. The NIH will accept
electronic applications only from organizations that have completed all
necessary registrations.

1.
Request Application Information

Applicants
must download the SF424 (R&R) application forms and SF424 (R&R)
Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.

Prepare all applications using the SF424
(R &R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The
SF424 (R&R) Application Guide is critical to submitting a complete and
accurate application to NIH. There are fields within the SF424 (R&R)
application components that, although not marked as mandatory, are required by
NIH (e.g., the “Credential” log-in field of the “Research & Related
Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the
Application Guide. For additional information, see “Tips and Tools for
Navigating Electronic Submission” on the front page of “Electronic Submission of
Grant Applications.”

The SF424 (R&R)
application is comprised of data arranged in separate components. Some
components are required, others are optional. The forms package associated with
this FOA in Grants.gov/ APPLY will include all applicable components, required
and optional. A completed application in response to this FOA will include the
following components:

3.A.1. Letter of Intent A letter of intent is
not required for the funding opportunity.

3.B. Sending an
Application to the NIH

To submit an application
in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow
steps 1-4. Note: Applications must only be submitted electronicallyPAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application
Processing

Applications may be submitted to Grants.gov on or
after the opening date and must be submitted
no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission date(s).
(See Section IV.3.A. for all dates.) If an application is not submitted
by the submission date(s) and time, the application may be delayed in the review
process or not reviewed.

Upon receipt, applications will be transferred from Grants.gov to the
NIH Electronic Research Administration process for validation. Both the PD/PI
and the Signing Official for the organization must verify the submission via Commons within 2 business days
of notification of the NIH validation.

Upon receipt, applications will be evaluated for completeness by the
Center for Scientific Review, NIH. Incomplete applications will not be
reviewed.

The NIH will not accept any application in response to this FOA that
is essentially the same as one currently pending initial merit review unless
the applicant withdraws the pending application. The NIH will not accept any
application that is essentially the same as one already reviewed. This does not
preclude the submission of an application already reviewed with substantial
changes, but such application must include an “Introduction” addressing the
previous critique. Note that such an application is considered a
"resubmission" for the SF424 (R&R).

There will be an acknowledgement of receipt of
applications from Grants.gov and the Commons. Information related to the
assignment of an application to a Scientific Review Group is also in the Commons.

All
NIH awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy
Statement.

Pre-Award
Costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new award if such
costs: are necessary to conduct the project and would be allowable under the
grant, if awarded, without NIH prior approval. If specific expenditures would
otherwise require prior approval, the grantee must obtain NIH approval before
incurring the cost. NIH prior approval is required for any costs to be incurred
more than 90 days before the beginning date of the initial budget period of a
new award.

The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential”
log-in field of the “Research & Related Senior/Key Person Profile”
component. The applicant organization must include its DUNS number in its
Organization Profile in the eRA Commons. This DUNS number must match the DUNS
number provided at CCR registration with Grants.gov. For additional
information, see “Tips and Tools for Navigating Electronic Submission” on the
front page of “Electronic Submission of Grant
Applications.”

All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 applications:

R21 applications will use the modular budget format and
"Just-in-Time" concepts, with direct costs requested in $25,000
modules, up to the total direct costs limitation of $275,000 over an R21
two-year period. No more than $200,000 in direct costs will be allowed in any
single year.

Items 2-5 of the Research Plan of the R21 application may
not exceed 15 pages, including tables, graphs, figures, diagrams, and charts.

Introduction (required for a resubmission application) is limited to one page.

Preliminary data are not required but may be included if
available.

Note: While
each section of the Research Plan needs to be uploaded separately as a PDF
attachment, applicants are encouraged to construct the Research Plan as a
single document, separating sections into distinct PDF attachments just before
uploading the files. This approach will enable applicants to better monitor
formatting requirements such as page limits. All attachments must be provided
to NIH in PDF format, filenames must be included with no spaces or special
characters, and a .pdf extension must be used.

R21 appendix
materials should be limited, as is consistent with the exploratory nature of
the R21 mechanism. The following materials may be included in the Appendix:

Up to five
publications, manuscripts (accepted for publication), abstracts,
patents, or other printed materials directly relevant to this project. Do
not include manuscripts submitted for publication.

Publications in
press: Include only a publication list with a link to the on-line journal
article or the PubMed Central (PMC) submission identification number. Do not
include the entire article.

Manuscripts
accepted for publication but not yet published: The entire article may be
submitted electronically as a PDF attachment.

Manuscripts
published but an online journal link is not available: The entire article may
be submitted electronically as a PDF attachment.

Graphic images of gels, micrographs, etc. provided that
the image (may be reduced in size) is also included within the 15-page limit of
Items 2-5 of the Research Plan. No images may be included in the Appendix
that are not also represented within the Research Plan.

Do not use the Appendix to circumvent the page limitations
of the Research Plan. An application that does not observe these limitations may be delayed in the review process.

Specific
Instructions for Modular Grant applications.

Applications requesting direct costs in each year of
$250,000 or less (excluding consortium F&A costs), must be submitted in a
modular budget format using the Modular Budget Component provided in the SF424
(R&R) Application Package and Instructions Guide (see specifically Section
5.4). The modular budget format simplifies the preparation of the budget in
these applications by limiting the level of budgetary detail. Applicants
request direct costs in $25,000 modules.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary,
depending on the data being collected and how the investigator is planning to
share the data. Applicants who are planning to share data may wish to describe
briefly the expected schedule for data sharing, the format of the final
dataset, the documentation to be provided, whether or not any analytic tools
also will be provided, whether or not a data-sharing agreement will be required
and, if so, a brief description of such an agreement (including the criteria
for deciding who can receive the data and whether or not any conditions will be
placed on their use), and the mode of data sharing (e.g., under their own
auspices by mailing a disk or posting data on their institutional or personal
website, through a data archive or enclave). Investigators choosing to share under
their own auspices may wish to enter into a data-sharing agreement. References
to data sharing may also be appropriate in other sections of the application.

All applicants must
include a plan for sharing research data in their application. The data sharing
policy is available at https://grants.nih.gov/grants/policy/data_sharing.
All investigators responding to this funding opportunity should include a
description of how final research data will be shared, or explain why data
sharing is not possible.

The reasonableness
of the data sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.

The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, https://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.

Section
V. Application Review Information

1. Criteria

Only the review
criteria described below will be considered in the review process.

2. Review and Selection Process

Applications
submitted for this funding opportunity will be assigned to the ICs on the basis
of established PHS referral guidelines.

Undergo a
selection process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score.

Receive a
written critique.

Receive a
second level of review by an appropriate national advisory council or
board.

The
following will be considered in making funding decisions:

Scientific
merit of the proposed project as determined by peer review

Availability
of funds

Relevance to
program priorities

The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their
written critiques, reviewers will be asked to comment on each of the following
criteria in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a high priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.

Significance: Does this study address an
important problem? If the aims of the application are achieved, how will
scientific knowledge or clinical practice be advanced? What will be the effect
of these studies on the concepts, methods, technologies, treatments, services,
or preventative interventions that drive this field?

Approach: Are the conceptual or
clinical framework, design, methods, and analyses adequately developed, well
integrated, well reasoned, and appropriate to the aims of the project? Does the
applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and
innovative? For example: Does the project challenge existing paradigms or
clinical practice; address an innovative hypothesis or critical barrier to
progress in the field? Does the project develop or employ novel concepts,
approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators
appropriately trained and well suited to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
other researchers? Does the investigative team bring complementary and
integrated expertise to the project (if applicable)?

Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?

2.A. Additional Review
Criteria:

In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:

Protection
of Human Subjects from Research Risk: The involvement of human subjects and protections from
research risk relating to their participation in the proposed research will be
assessed. See item 6 of the Research Plan component of the SF424 (R&R).

Inclusion
of Women, Minorities and Children in Research: The adequacy of plans to
include subjects from both genders, all racial and ethnic groups (and
subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated. See item 7 of the Research Plan component of the SF424
(R&R).

Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under item 11 of the Research
Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.

2.B. Additional Review
Considerations

Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed research
may be assessed by the reviewers. Is the percent effort listed for the PD/PI
appropriate for the work proposed? Is each budget category realistic and
justified in terms of the aims and methods?

Period of Support: The appropriateness of the
requested period of support in relation to the proposed research.

2.C. Sharing
Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific
merit or the priority score. The presence of a data sharing plan will be part
of the terms and conditions of the award. The funding organization will be
responsible for monitoring the data sharing policy.

Program staff will be responsible for the
administrative review of the plan for sharing research data.

2.D. Sharing
Research Resources

NIH
policy requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (See NIH Grants Policy Statementhttps://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.

Program staff will be responsible
for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be
considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each Non-Competing Grant
Progress Report (PHS 2590), See Section VI.3.,
“Reporting.”

3. Anticipated Announcement and Award DatesNot applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written
critique) via the eRA Commons.

A formal notification in the form of a Notice of Award
(NoA) will be provided to the applicant organization. The NoA signed by the
grants management officer is the authorizing document. Once all administrative
and programmatic issues have been resolved, the NoA will be generated via email
notification from the awarding component to the grantee business official.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.

2. Administrative and
National Policy Requirements

The terms and conditions
of the award may include specific requirements for data and/or resource sharing
including depositing virus strains, cell lines, DNA samples, biomaterials or
other mouse and animal models into National repositories.

We encourage your
inquiries concerning this funding opportunity and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into three
areas: scientific/research, peer review, and financial or grants management
issues:

Human Subjects Protection:Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and others,
and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:Data and safety monitoring is required for all types
of clinical trials, including physiologic toxicity and dose-finding studies
(Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative
trials (Phase III). Monitoring should be commensurate with risk. The
establishment of data and safety monitoring boards (DSMBs) is required for multi-site
clinical trials involving interventions that entail potential risks to the
participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants
and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators submitting an NIH application seeking
$500,000 or more in direct costs in any single year are expected to include a
plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their
institutions on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of scientific merit or the priority score.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1) first
produced in a project that is supported in whole or in part with Federal funds
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statementhttps://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical
Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R); and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical
Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them.

Required Education on the Protection of Human
Subject Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):Criteria for federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC
line(s)to be used in the proposed research. Applications that do not provide
this information will be returned without review.

NIH Public Access Policy:NIH-funded investigators are requested to submit to
the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov)
at PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts
resulting from 1) currently funded NIH research projects or 2) previously
supported NIH research projects if they are accepted for publication on or
after May 2, 2005. The NIH Public Access Policy applies to all research grant
and career development award mechanisms, cooperative agreements, contracts,
Institutional and Individual Ruth L. Kirschstein National Research Service Awards,
as well as NIH intramural research studies. The Policy applies to
peer-reviewed, original research publications that have been supported in whole
or in part with direct costs from NIH, but it does not apply to book chapters,
editorials, reviews, or conference proceedings. Publications resulting from
non-NIH-supported research projects should not be submitted.

Standards for Privacy of Individually Identifiable
Health Information:The Department of Health and Human Services (DHHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
Website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:All applications and proposals for NIH funding must be
self-contained within specified page limitations. Unless otherwise specified in
an NIH solicitation, Internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Furthermore, we caution reviewers that their
anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:The Public Health Service (PHS) is committed to achieving
the health promotion and disease prevention objectives of "Healthy People
2010," a PHS-led national activity for setting priority areas. This PA is
related to one or more of the priority areas. Potential applicants may obtain a
copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:This
program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections 301
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The NIH Grants Policy
Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to
provide a smoke-free workplace and discourage the use of all tobacco products.
In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a facility) in
which regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.

Loan Repayment Programs:NIH encourages applications for educational loan
repayment from qualified health professionals who have made a commitment to
pursue a research career involving clinical, pediatric, contraception,
infertility, and health disparities related areas. The LRP is an important
component of NIH's efforts to recruit and retain the next generation of researchers
by providing the means for developing a research career unfettered by the
burden of student loan debt. Note that an NIH grant is not required for
eligibility and concurrent career award and LRP applications are encouraged.
The periods of career award and LRP award may overlap providing the LRP
recipient with the required commitment of time and effort, as LRP awardees must
commit at least 50% of their time (at least 20 hours per week based on a 40
hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.